Colorimetry, Acetaminophen

FDA product code LDP · 37 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3030
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1980-06-20 – 2026-07-24

LDP 2026-07-24

Atellica CH Acetaminophen 2 (ACTM)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K261364

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LDP 2022-02-18

Acetaminophen

Applicant Sekisui Diagnostics P.E.I., Inc.

K number K202644

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LDP 2019-02-08

SEKURE Acetaminophen L3K Assay

Applicant Sekisui Diagnostics P.E.I., Inc.

K number K180835

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LDP 2011-12-23

ROCHE ACETAMINOPHEN ASSAY

Applicant Roche Diagnostics

K number K110726

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LDP 2010-08-02

ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138

Applicant Siemens Healthcare Diagnostics

K number K100200

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LDP 2009-05-01

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

Applicant Genzyme Diagnostics P.E.I., Inc.

K number K081938

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LDP 2006-07-10

DIMENSION VISTA FLEX REAGENT CARTRIDGES

Applicant Dade Behring, Inc.

K number K061655

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LDP 2005-02-28

TRIAGE TOX DRUG SCREEN

Applicant Biosite Incorporated

K number K043242

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LDP 2005-01-07

ACETAMINOPHEN-SL ASSAY

Applicant Diagnostic Chemicals , Ltd.

K number K042330

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LDP 2002-07-11

ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Applicant Bayer Diagnostics Corp.

K number K020792

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LDP 2002-01-08

ROCHE ACETAMINOPHEN

Applicant Roche Diagnostics Corp.

K number K013757

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LDP 2001-06-08

SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO

Applicant Beckman Coulter, Inc.

K number K011465

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LDP 2000-10-11

EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL

Applicant Dade Behring, Inc.

K number K002974

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LDP 2000-04-14

SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT

Applicant Beckman Coulter, Inc.

K number K000494

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LDP 1999-07-22

COBAS INTEGRA ACETAMINOPHEN

Applicant Roche Diagnostics Corp.

K number K991598

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LDP 1998-05-12

ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.

Applicant Diagnostic Chemicals , Ltd.

K number K981059

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LDP 1998-03-03

ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10

Applicant Diagnostic Chemicals , Ltd.

K number K980031

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LDP 1996-09-23

ACETAMINOPHEN FLEX REAGENT CARTRIDGE

Applicant Dade Intl., Inc.

K number K963244

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LDP 1996-07-08

ACETAMINOPHEN SERUM TOX EIA ASSAY

Applicant Diagnostic Reagents, Inc.

K number K961373

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LDP 1995-12-18

EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K954933

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LDP 1995-09-06

ACETAMINOPHEN ASSAY

Applicant Diagnostic Chemicals , Ltd.

K number K952949

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LDP 1995-08-24

AXSYM ACETAMINOPHEN

Applicant Abbott Laboratories

K number K953094

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LDP 1993-07-08

ACETASITE

Applicant Gds Diagnostics

K number K931257

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LDP 1990-05-10

SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM

Applicant Medisense, Inc.

K number K897118

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LDP 1989-01-11

ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K885097

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LDP 1988-08-08

EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653

Applicant Em Diagnostic Systems, Inc.

K number K882719

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LDP 1988-05-27

GDS ENZYMATIC ACETAMINOPHEN REAGENT

Applicant Gds Technology, LLC

K number K880829

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LDP 1985-04-17

ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870

Applicant Stanbio Laboratory

K number K851278

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LDP 1985-01-18

EMIT QST ACETAMINOPHEN ASSAY

Applicant Syva Co.

K number K844962

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LDP 1984-08-16

ACA ACETAMINOPHEN ANALYTICAL TEST PACK

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K842548

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LDP 1984-05-11

TDX ACETAMINOPHEN

Applicant Abbott Laboratories

K number K840941

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LDP 1983-10-04

ACETAMINOPHER ASSAY KIT

Applicant Quantimetrix Corp.

K number K832045

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LDP 1983-09-12

ACETAMINOPHEN(PARACETAMOL

Applicant Bio-Analytics Laboratories, Inc.

K number K832567

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LDP 1982-08-24

PROCEDURE #430 & REAGENTS FOR ACETAMIN

Applicant Sigma Chemical Co.

K number K822313

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LDP 1982-07-16

ACETAMINOPHEN STAT-PAK REAGENT SET

Applicant Clin Tech Diagnostics Corp.

K number K821969

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LDP 1982-05-28

EMIT-TOX ACETAMINOPHEN ASSAY

Applicant Syva Co.

K number K821379

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LDP 1980-06-20

STANBIO ACETAMINOPHEN TEST SET #0850

Applicant Stanbio Laboratory

K number K801014

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